Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia
Authors Dixon CM, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Larson TR, Mynderse LA
Received 12 August 2016
Accepted for publication 12 September 2016
Published 21 November 2016 Volume 2016:8 Pages 207—216
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Dr Jan Colli
Christopher M Dixon,1 Edwin Rijo Cedano,2 Dalibor Pacik,3 Vítězslav Vit,3 Gabriel Varga,3 Lennart Wagrell,4 Thayne R Larson,5 Lance A Mynderse6
1Department of Urology, Phelps Memorial Hospital, Sleepy Hollow, New York, NY, USA; 2Department of Urology, Clinical Canela, La Romana, Dominican Republic; 3Department of Urology, Brno University Hospital, Brno, Czech Republic; 4Urologcentrum, Stockholm, Sweden; 5Institute of Medical Research, Scottsdale, AZ, 6Department of Urology, Mayo Clinic, Rochester, MN, USA
Objective: The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.
Patients and methods: Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months.
Results: LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen.
Conclusion: The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.
Keywords: benign prostatic hyperplasia, lower urinary tract symptoms, convective RF, water vapor thermal therapy, minimally invasive
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